Danish pharmaceutical company ALK-Abelló A/S (ALK) (CPH:ALK-B) said on Friday that it has received approval from Health Canada for its ACARIZAX tablet to treat children aged five to 11 with house dust mite-induced allergic rhinitis.

This approval expands ACARIZAX's indication in Canada to include patients from age five to 65.

Canada remains a key market for ALK's respiratory tablet portfolio, with sales recording continuous double-digit growth. The broader indication is expected to support further market expansion.

The latest approval follows the MT-12 Phase 3 clinical trial, the largest paediatric AIT study to date, involving 1,460 children in North America and Europe. The trial confirmed the tablet's efficacy and safety, with findings recently published in The Lancet Regional Health – Europe.

ACARIZAX is approved for various age groups in Canada, Europe, the USA, and Japan, with ongoing regulatory reviews in other global markets. It is marketed under different names, including ODACTRA in the USA and MITICURE in Japan.

Regulatory reviews for ALK's tree pollen allergy tablet, ITULAZAX, are ongoing in Europe and Canada, with decisions expected by mid-2025. The company aims to cover 80% of the most common respiratory allergies with its tablets for children, adolescents and adults.

ALK confirmed that this approval does not affect its 2025 financial guidance.